'Abuse-Deterrent' Label Panned for New Opioid

The FDA has approved another abuse-deterrent opioid, although addiction experts said the drug can still be easily abused.

The FDA has approved another abuse-deterrent opioid, although addiction experts said the drug can still be easily abused.

The agency approved Purdue Pharma's combination of oxycodone and naloxone (Targiniq) to treat pain that is "severe enough to require daily, around-the-clock" therapy that hasn't responded to other opioids.

That's because of the way naloxone is processed when taken orally, said David Juurlink, MD, PhD, a medical toxicologist at the University of Toronto. It can exert its effects on opioid receptors in the brain if injected into the bloodstream or taken intranasally. But when ingested, it's not absorbed well.

Chewing and swallowing will thus enable abusers to get the full 12-hour oxycodone dose all at once, said Andrew Kolodny, MD, chief medical officer of Phoenix House, a substance abuse rehabilitation program.

"This product is obviously inferior to OxyContin and should certainly not be labeled abuse-deterrent," Kolodny said. (Purdue Pharma also makes OxyContin.)

Lewis Nelson, MD, a medical toxicologist at NYU Langone Medical Center, noted that other opioid products containing naloxone, such as the addiction treatment Suboxone (a combination of buprenorphine and naloxone), have been subject to abuse "so the underlying assumption that adding naloxone to an opioid completely prevents abuse is potentially misguided."

"Since most abuse and overdose occurs through ingestion, and since this combination provides no risk reduction when taken by that route, it seems that adding the abuse-deterrent moniker is premature," Nelson said.

Addiction experts noted that the agency approved Targiniq without consulting an advisory committee, basing its approval instead on its review of the results of a trial involving 601 patients with chronic lower back pain.

"There's no justification for approving the drug without an advisory committee meeting considering how controversial the topic is," Kolodny said. "I'm almost certain an advisory committee would have voted this product down."

The agency is, however, requiring postmarketing studies of Targiniq to assess the risks of misuse, abuse, hyperalgesia, addiction, overdose, and death associated with use longer than 12 weeks, and the company will also have to study the effects of its abuse-deterrent features.

Targiniq will also come with a risk evaluation and mitigation strategy, the agency said.

Still, Kolodny expressed concerns that the drug "could actually worsen the epidemic by leaving prescribers and patients with a false sense of security."

In an FDA Voice blog released Thursday afternoon, Douglas Throckmorton, MD, deputy director of regulatory programs at FDA’s Center for Drug Evaluation and Research, warned about the limitations and the uncertainties of abuse-deterrent formulations.

"Care must be taken in putting too much promise into abuse-deterrent technology at this time because the science is still relatively new and evolving," Throckmorton wrote. "While the FDA strongly supports the development of products with effective abuse-deterrent properties and believes they can make a real difference, abuse-deterrent properties do not make an opioid impossible to abuse, and do not prevent overdose and death."

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